FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant Gel
K Number: K172977
·
Decision Jan 16, 2018
Classifications
1
FEI Numbers
137
Registration Numbers
137
Same Product Code
418
Applicant Total
8
Review Days
111
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Basic Information
- Device Name
- Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant Gel
- K Number
- K172977
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nanova Biomaterials, Inc.
- Date Received
- September 27, 2017
- Decision Date
- January 16, 2018
- Product Code
- KLE
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KLE | Agent, Tooth Bonding, Resin | FDA class 2 | Dental |
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|---|---|---|---|
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| K161174 | Nanova Interference Screw | Nov 3, 2016 | Substantially Equivalent |
| K151943 | Vas-Q-Clip | Mar 25, 2016 | Substantially Equivalent |
| K152004 | Nanova Universal Composite | Nov 17, 2015 | Substantially Equivalent |
| K150623 | Nanova Flowable Composite | Jun 18, 2015 | Substantially Equivalent |
| K140349 | STARBRIGHT 5% SODIUM FLUORIDE VARNISH | Sep 22, 2014 | Substantially Equivalent |